Fibre Specific Signalling in the Locomotor Myopathy of Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Fibre Specific Signalling in the Locomotor Myopathy of COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01471587
• Other study ID #: ERICA WP1b
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2011
• Last updated: December 1, 2011
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: December 2011
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

Skeletal muscle is composed of two fibre types which are intertwined. Skeletal muscle weakness, particularly of the walking muscles, is an important complication of Chronic Obstructive Pulmonary Disease (COPD) but so far the investigators do not know what mechanisms drive the process.

All existing studies have investigated signalling pathways in the whole muscle so they have been forced to consider type I and type II fibres together. It is possible that disease selectively affects one fibre type, most likely type I fibres which are in fact lost in COPD patients. For this reason mechanisms of disease may have been overlooked by current studies.

The applicants have acquired the technology which allows type I and type II fibres in a muscle specimen to be split (by laser capture microdissection) and so signalling pathways can be assessed separately in type II and type I fibres which is what this proposal sets out to do.

The proposal therefore aims to capture well characterised clinical data from 60 COPD patients and 20 age matched controls, from whom a biopsy of the main walking muscle, the quadriceps, will be taken. In the samples the investigators will assess at a fibre specific level inflammatory signalling. Surplus material will be retained for subsequent fibre specific analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Male or female aged 40 - 90 years inclusive.

• A clinical diagnosis of COPD based on spirometry (FEV1/FVC ratio < 70% on entry to the study with FEV1 < 80% predicted)

Exclusion Criteria:

• History or current diagnosis of alpha 1-anti-trypsin deficiency, asthma, lung cancer, bronchiectasis or other significant respiratory disease (including treated TB in the past 10 years)

• Contraindication to biopsy for research purpose (e.g. use of anticoagulant in the 1 week prior to biopsy)

• Joint or neurological disease which on its own would preclude exercise

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London	UK

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory signalling at a fibre specific level		2 years	No